The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals and Its Effect on Iron Status of Rural Indian Children (6-10 Years) (MUGUST_2)
|ClinicalTrials.gov Identifier: NCT01191463|
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : September 29, 2011
Iron deficiency is estimated to affect about one fifth of the world's population, and women and children are among the most severely affected. Evidence is mounting that iron deficiency anemia adversely affects brain development with measurable effects on children's behavior, motor development and cognition. In Hisar district of Haryana state, north- India, 58% of school age children (6-10 years) are anemic, 49 % are iron deficient whereas 40 % have been found to be anemic due to iron deficiency. Iron bioavailability calculated using algorithms in regional diets ranged from 3.2 to 4.6 percent. Mungbean (Vigna radiata L.) is the third most important legume crop of India. It is a high potential legume crop with 4-8 mg of iron and known as a nutritious and healthy legume. Ascorbic acid is a potent enhancer of iron absorption in humans which can counteract the inhibitory effect of phytic acid and polyphenols. Guava is a popular and easily available fruit for this community having 200- 300 mg/100g of ascorbic acid. We will conduct a randomised controlled trial in school age children (6-10 years) in Haryana state of India, to determine the efficacy of local vitamin-C rich fruit guava with mungbean based meal on iron status of rural Indian children.
Objective: To assess the effect of mungbean based test meal on iron status (as body iron stores, defined and calculated by the ratio of serum ferritin and serum transferrin receptor) of school age children (6-10 years) with and without the consumption of guava, a vitamin C rich fruit, in a school feeding program for seven months.
Study population: Three hundred school children aged between 6-10 years will be recruited from two government school of Mangali village situated in Hisar district of Haryana state.
Study design: This intervention study will be carried out in a randomized controlled design. Main study parameters/endpoints: Primary outcome will be the measurement of body iron stores (mg/kg of body weight) based on the ratio of serum transferrin receptor to serum ferritin.
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia||Other: Mung Bean Meal Other: Guava||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals in Indian Children (6-10 Years)|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Experimental: Mung Bean Meals and Guava fruit
Subject in this group will receive, a lunch meal based on 50g of Mung beans together with a local, Vitamin C rich fruit (Guava)
Other: Mung Bean Meal
50g mung beans will be cooked to a curry with oil, spices and small amounts of vegetables.Other: Guava
A fresh Guava fruit will be provided raw (approx 100g fresh weight)
Active Comparator: Mung Bean
Subjects in this group will receive a lunch meal based on 50g mung beans but without any vitamin C source.
Other: Mung Bean Meal
50g mung beans will be cooked to a curry with oil, spices and small amounts of vegetables.
No Intervention: School feeding program
Subjects in this arm, will receive the regular school feeding program as provided by the school authorities
- Body Iron Stores [ Time Frame: Baseline (Start month=0), End of study (Month=7) ]Defined as the ration between serum ferritin and soluble serum transferrin recpetor Body iron stores are a sensitive measure of body iron balance and indicative of body iron changes.
- Prevalence of iron deficiency, Prevalence of Iron deficiency anemia [ Time Frame: Begin (Month=0), End (Month=7) ]Anemia will be defined as a hemoglobin concentration <11.5g/L and iron deficiency will be defined as an SF concentration <12µg/l.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191463
|CCS Haryana Agricultural University|
|Hisar, Haryana State, India|
|Principal Investigator:||Varsha Rani, PhD||Wageningen University, Haryana University|